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HEMOTECH AVFHEMO Safety System A.V. Fistula Needle Set
EUDAMEDClass IIa (EU MDR)
Ref A15R25B30SModel 862-1526Ref A15R25B15SModel 862-1525Ref A16R25B15SModel 862-1636Ref V15R20-30SModel 862-1527Ref A16R20B30SModel 862-1634Ref A15R20B30SModel 862-1524Ref V16R25-30SModel 862-1639Ref V17R20-30SModel 862-1724Ref A16R20B15SModel 862-1632Ref V16R20-30SModel 862-1635Ref A17R20B30SModel 862-1723
Identity
- Trade Name
- HEMOTECH AVFHEMO Safety System A.V. Fistula Needle Set EUDAMED
- Device Name
- SYSLOC AVF EUDAMED
- Model / Reference
- 862-1526 EUDAMEDA15R25B30S EUDAMED862-1525 EUDAMEDA15R25B15S EUDAMED862-1636 EUDAMEDA16R25B15S EUDAMED862-1527 EUDAMEDV15R20-30S EUDAMED862-1634 EUDAMEDA16R20B30S EUDAMED862-1524 EUDAMEDA15R20B30S EUDAMED862-1639 EUDAMEDV16R25-30S EUDAMED862-1724 EUDAMEDV17R20-30S EUDAMED862-1632 EUDAMEDA16R20B15S EUDAMED862-1635 EUDAMEDV16R20-30S EUDAMED862-1723 EUDAMEDA17R20B30S EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-862-1526AP EUDAMEDD-862-1525AM EUDAMEDD-862-1636AX EUDAMEDD-862-1527AR EUDAMEDD-862-1634AT EUDAMEDD-862-1524AK EUDAMEDD-862-1639B5 EUDAMEDD-862-1724AV EUDAMEDD-862-1632AP EUDAMEDD-862-1635AV EUDAMEDD-862-1723AT EUDAMED
- Basic UDI-DI
- B-862-1526AP EUDAMEDB-862-1525AM EUDAMEDB-862-1636AX EUDAMEDB-862-1527AR EUDAMEDB-862-1634AT EUDAMEDB-862-1524AK EUDAMEDB-862-1639B5 EUDAMEDB-862-1724AV EUDAMEDB-862-1632AP EUDAMEDB-862-1635AV EUDAMEDB-862-1723AT EUDAMED
- EMDN Code
- A010401 ARTERIOVENOUS FISTULA NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
HEMOTECH AVFHEMO Safety System A.V. Fistula Needle Set by Jms Singapore Pte Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-862-1526AP | Class IIa | Active |
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Manufacturer
- Manufacturer
- JMS Singapore Pte Ltd
- EUDAMED SRN
- SG-MF-000024704
- Authorised Representative
- Bionic Medizintechnik GmbH DE-AR-000012049
Sources (11)
- EUDAMED c9b15f50-5e3f-4e12-a5b7-772cdea70a75 61 fields · synced Oct 6, 2026
- EUDAMED 513ac192-8be0-41b8-8160-f67cc96d390b 61 fields · synced May 16, 2026
- EUDAMED 22c18231-f0c5-4c9c-946c-4a029b80e8a7 61 fields · synced May 16, 2026
- EUDAMED e2cfbc89-24fe-49ef-9030-ac1440eb4ba1 61 fields · synced May 17, 2026
- EUDAMED 2642b637-3c62-4100-9dd7-d5f7144f4163 61 fields · synced May 17, 2026
- EUDAMED 2c1aa1e7-7bcb-4b64-8025-bf5ea865b801 61 fields · synced May 17, 2026
- EUDAMED 0493d053-b332-4834-9971-e3e937f1f515 61 fields · synced May 18, 2026
- EUDAMED 37334c85-78ec-44ab-8aae-529896e891cd 61 fields · synced May 18, 2026
- EUDAMED d5e81e8f-12b6-45f0-b1ba-054cdde4c7a4 61 fields · synced May 18, 2026
- EUDAMED 91f2de5f-1a49-4e96-a0c3-87baa0eef3f1 61 fields · synced May 18, 2026
- EUDAMED 0cd1f2c3-bda5-4ba6-b18c-4b67f3f46e6f 61 fields · synced May 19, 2026